DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The scope of claim 8 appears to be substantially the same as claim 1 from which it depends. Claim 8 recites the inflammation is related to subarachnoid hemorrhage, but claim 1 already recites “identifying the patient as having a subarachnoid hemorrhage…” and “stimulating, in the patient suffering from inflammation associated with the subarachnoid hemorrhage…” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 8, 10, 14-17, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manogue (US 2020/0094055) in view of Gill et al. (US 2024/0042203).
With regard to claims 1 and 20, Manogue discloses a method of treating an inflammation in a patient comprising; stimulating in a patient suffering from inflammation, a patient’s vagus nerve with an electrical signal to achieve a therapeutic effect for treating the inflammation (e.g. paragraph 29 and 39), and re-stimulating the patient's vagus nerve a second time within 24 hours of a first stimulation, wherein the electrical signal for the first stimulation and a second stimulation are the same (e.g. paragraph 51).
Manogue fails to explicitly teach identifying the patient as having a subarachnoid hemorrhage or as being at risk for post-SAH inflammatory response and the stimulation is in a patient suffering from inflammation associated with subarachnoid hemorrhage. Manogue details the vagal stimulation protocol is designed to treat inflammation broadly but stops short of identifying the specific type of inflammation being subarachnoid hemorrhage inflammatory response.
Gill discloses a system and method for vagal nerve stimulation for the purpose of treating inflammatory response and specifically for treating inflammatory response from a subarachnoid hemorrhage as set forth in paragraph 27 and 67. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Manogue with adapting the system and method to specifically treat subarachnoid hemorrhage inflammation since such a modification would provide the predictable results of providing a similar known treatment method for a specific type of disorder. Examiner notes that any disclosure of treatment specifically for subarachnoid hemorrhage inflammation would necessarily require the steps of identifying the individual as first having subarachnoid hemorrhage inflammation. In short, there must be a reasonable expectation that a user would not administer treatment for a particular disorder without first ensuring the patient is suffering from the disorder in order to avoid potential patient harm.
Regarding Claims 2 and 14, Manogue discloses wherein the stimulation is transcutaneous stimulation of the vagus nerve (e.g. paragraph 9).
Regarding Claims 3 and 15, Manogue discloses wherein the stimulation is provided via a first electrode and a second electrode, wherein the first electrode and the second electrode are attached to the concha of the patient's ear (e.g. paragraph 40).
Regarding Claims 4 and 16, Manogue discloses wherein the first electrode and the second electrode are attached to the patient's left ear (e.g. paragraph 40, 52 and Fig. 1).
Regarding Claims 5 and 17, Manogue discloses the stimulation is provided to the auricular branch of the vagus nerve where the vagus nerve travels in the pinna of the ear (e.g. paragraph 20 and 35).
Regarding Claim 8, as discussed above with respect to 35 USC 112d rejection, claim 8 recites substantially the same limitation recited in claim 1, the inflammation being a result of subarachnoid hemorrhage. The rejection above with respect to claim 1 has already addressed this limitation.
Regarding Claims 10, see rejection of Claim 1 above. Manogue further discloses one or more electrodes included in the device (e.g. paragraph 61).
Regarding Claim 21-24, Manogue discloses wherein a signal current is 0.4 mA, a pulse width is 250us, a signal frequency is 20 Hz, and a signal on-time is twenty minutes (see par. 42)
Claim(s) 6-7, 9, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manogue in view of Gill as applied above, further in view of Schwab et al. (US 2017/0120046).
Regarding Claims 6 and 18, Manogue in view of Gill as applied above discloses stimulation is paired with pharmacological therapies (see par. 36), but does not specify antibiotics or anti- inflammatory medication. Schwab discloses a similar treatment for inflammation that combines electrical stimulation with anti-inflammatory medication (see par. 30). It would have been obvious to one of ordinary skill in the art at the time of the invention to include pharmacological agents because Schwab teaches it helps to modulate nervous system activity (see par. 41).
Regarding Claims 7 and 19, Manogue in view of Gill, does not disclose a cuff electrode. Schwab discloses an implanted electrode for direct stimulation of the nerve (see par. 54 and 61). It would have been obvious to one of ordinary skill in the art at the time of the invention to use a cuff electrode placed directly on the vagus nerve because Schwab teaches direct stimulation can be beneficial in some applications (see par. 40). Additionally, or alternatively, Schwab teaches direct stimulation is a known technique for achieving stimulation of the vagus nerve and it would have been obvious to one having ordinary skill in the art at the time the invention was made to select between any known technique for stimulating the vagus nerve as long as there would be a reasonable expectation of success.
Regarding Claim 9, Manogue in view of Gill disclose the invention as claimed but fails to teach receiving and analyzing a plurality of patient attributes associated with the patient; analyzing the plurality of patient attributes to determine that the patient is at risk for a spontaneous subarachnoid hemorrhage (SAH) based on the analyzed patient attributes. Schwab further discloses receiving and analyzing a plurality of patient attributes associated with the patient; analyzing the plurality of patient attributes to determine that the patient is at risk for a spontaneous subarachnoid hemorrhage (SAH) based on the analyzed patient attributes (see par. 6, 65-67). It would have been obvious to one of ordinary skill in the art at the time of the invention to determine SAH risk using the patient's physiological parameters because Schwab teaches, they are associated with immune function and can predict how the system will behave (e.g. paragraphs 61 and 64).
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive. Applicants’ arguments relate to the amended claims. Specifically, Applicant has further limited the claims by amending the claim language to require identifying the patient as having subarachnoid hemorrhage and the stimulation treating the subarachnoid hemorrhage. As discussed above, this claim amendment is substantially similar in scope to Claim 8. Additionally, the rejection of Manogue in view of Gill fully addresses this limitation in combination with the other claim limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A STOKLOSA whose telephone number is (571)272-1213. The examiner can normally be reached M-F 930AM-530PM.
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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